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Washington State University

HRPP policies & procedures manual

501: Categories of research

1. Purpose

The policy describes the review of specific types of research that require additional considerations by the IRB.

2. Policy

The categories of research defined in these policies involve either methodologies that might require additional considerations or for which there are federally mandated determinations that IRB are required to make and document. These categories of research include, but are not limited to:

  • Genetic research
  • Prospective research in emergency settings
  • Emergency use of an investigational article
  • Medical records and chart review
  • Residual body fluids, tissues, and recognizable body parts
  • Biomedical research
  • Radiation materials
  • Oral history
  • Prospective tissue banking
  • Classroom projects/activities
  • Graduate student research
  • Internet (or on-line, computer) based research
  • Recording (photographs, audio, video)
  • Suicide/depression
  • Undergraduate student activities

3. Specific policies

3.1 Genetic research

Genetic research may require special considerations.  At first consideration, much genetic research may appear to meet the criteria for expedited review.  This includes:

  • Pedigree studies, which look for a pattern of inheritance of a gene
  • Positional cloning studies, which are conducted to identify particular genes
  • Diagnostic studies, which gather samples to develop techniques to determine the presence of specific DNA mutations

However, these studies may create a vulnerable population and subjects’ autonomy may be compromised. Therefore, the ORA director, IRB chair or the ORB coordinator may request the full IRB to review these studies to answer the following questions:

  • Will the samples be made anonymous to maintain confidentiality? If not, to what extent will the results remain confidential and who will have access to them?
  • Will the samples be used for any additional studies not made explicit at the time of donation, or will the samples be destroyed after specified, one-time use?
  • Will the donor be informed of any and all results obtained from his or her DNA?
  • Will the sample be sold in the future?
  • Will the donor be paid for his/her sample now or in the future?
  • Will the donor be informed of the results of the entire study?
  • Will family members be implicated in the studies? If so, they are subjects.

Gene therapy research (administration of recombinant vectors), which is carried out to develop treatments for genetic diseases at the DNA level, presents obvious and not so obvious questions, including considerations of delivery methods, target population, required follow-up.  Such protocols require use of external consultants to provide independent guidance to the IRB. If the project involves gene therapy to human subjects for other than clinical purposes, the study must be reviewed and approved by the National Institutes of Health Recombinant DNA Advisory IRB prior to IRB approval. Monitoring must be adequate, and a DSMB will be required.

Because there is still little regulatory guidance and relatively few ethical precedents, genetic research will require close scrutiny and the input of experts in this area.

3.2 FDA-regulated prospective research in emergency settings

WSU and its affiliates do not currently do prospective FDA-regulated research in emergency settings. When and if the University does do research in emergency settings, a procedure will be developed.

3.3 HHS-regulated prospective research in emergency settings

WSU and its affiliates do not do prospective research in emergency settings. When and if the University does do research in emergency settings, a procedure will be developed.

3.4 Emergency use of test (investigational) articles

WSU and its affiliates do not currently do research involving emergency use with a test article. When and if the University does do research involving emergency use of a test article, a procedure will be developed.

3.5 Medical records and chart review

Studies involving the use of existing publicly or privately held records may qualify for exempt status or expedited review. However, if the nature of the research could reasonably put subjects’ confidentiality at risk, the study will be reviewed by the full IRB. Studies that involve only chart and record review can sometimes pose significant risk to patients.

The most common breach of confidentiality is exposure of possible embarrassing information without the knowledge or consent of the patient. Such studies may also lead to recruitment of patients into future non-therapeutic studies in a manner that may provoke the patient to ask how his/her record was revealed to someone not part of his/her therapeutic team. The present policy is to require IRB review of studies involving chart review or data collection and analysis.

If identifiers were to be recorded, the research would require IRB review to ensure that, among other things, procedures for protecting privacy and confidentiality are adequate. Furthermore, the investigator studying cancer risk factors may propose to go on to contact the subjects (if still living) or family members (if the subject is deceased) to gather additional information, which may or may not be subject to the federal regulations.

3.6 Residual body fluids, tissues and recognizable body parts

Body fluids and tissues: Research on existing specimens (“on the shelf” or frozen) without identifying information (e.g., names, initials, hospital number, etc.) may be submitted to the IRB for exempt or expedited review.

3.7 Biomedical/biohazard research

In addition to IRB approval, the principal investigator will be required to obtain approval from the WSU Institutional Biosafety Committee, if necessary.

3.8 Radioactive materials

In addition to IRB approval, the principal investigator will be required to obtain approval from the WSU Radiation Safety Committee, if necessary.

3.9 Oral history

Historians and social scientists sometimes conduct interviews, or oral histories, with sources (knowledgeable people) to supplement written documents and artifacts in attempting to preserve information about past events.  Like journalists, historians interview sources to obtain eyewitness accounts of events.

Oral histories do not meet the definition of research and do not require IRB review and approval under the following conditions:

  • Focus is exclusively on past events, and
  • Purpose is conducted to understand or explain a particular past or unique event in history (and not contribute to generalizable knowledge or be applied to future activities).

There are additional considerations when reviewing oral history research proposals. Principal investigators should be familiar with the Oral History Association’s standards of ethics and should review John Neuenschwander’s Oral History and the Law. The following statements must be addressed in the proposal, if applicable:

  • The interviewee is given an opportunity to review and to approve of the conditions of us or publication of the data.
  • The interviewee is given an opportunity to provide informed consent to the interview. The consent form must state that the interviewee can refuse to answer any questions, can limit the time of the interview, and has the right to suggest topics that are not to be discussed during the interview.
  • The interviewee is given an opportunity to provide informed consent to the disposition of the records and/or access to the recordings. The consent form should indicate the rights of the subjects with regard to editing, access, copyright, prior use royalties, and the expected dissemination of all forms of the record. It should be noted that if the recordings are archived outside the researcher’s control, the research may not be able to anticipate all the uses of the record.
  • There must be adequate means provided for the protection of the privacy of any third parties (such as disguising the identities) of those who may be named in the interview. The researcher and the repository will follow conditions that the interviewee stipulates regarding dissemination of the interview, such as not publishing until after death or after a specific period of time. The repository must accept the interviewee’s conditions provided they are reasonable and legally acceptable. The accepted conditions must be noted in the cooperating repository’s letter.
  • The researcher must state any arrangement made to deposit interviews. The repository must be capable of preserving the interviews and making them available for general research. A letter of acceptance from the repository must be submitted with the research proposal.

3.10 Prospective tissue banking

A proposal must be submitted to the IRB describing the policies and procedures for the collection and handling of stored specimens. The IRB must be able to evaluate the procedures to ensure confidentiality and protection of the subjects. The proposal must address the following items:

  • How the specimens will be obtained, processed and stored
  • How the specimens will be labeled
  • How the clinical data will be associated with the specimen, and how the clinical data will be collected
  • What identifying information will be collected
  • How identifiers will be linked to specimens
  • What steps will be followed to maximize the confidentiality of linked identifiers
  • How specimens will be distributed
  • How the secondary distribution of specimens will be controlled
  • How the subjects’ rights will be protected with any future use of specimens not previously approved by the IRB
  • If results will be shared with subjects, how they will be shared
  • If minor subjects are used, how future adult consents will be secured
  • A separate consent form must be used to obtain permission for specimen banking.

3.11 Alcohol

Consistent with the National Advisory Council on Alcohol Abuse and Alcoholism, the University recognizes the legitimate and important need for research involving on the biological and behavioral effects of the ingestion of ethyl alcohol on human subjects.

It is essential that such research conform to the (ethical) principles that govern all research involving human subjects. These principles are elaborated upon in the latest report prepared for the National Institute on Alcohol Abuse and Alcoholism by the National Advisory Council on Alcohol Abuse and Alcoholism. The NIAAA website  provides information on research involving the administration of alcohol and also contains the latest NIAAA guidelines.

The IRB refers to and is guided by the NIAAA guidelines when reviewing research involving alcohol and researchers are strongly encouraged to review these guidelines prior to submitting applications to the IRB.

Depending on the nature of the research and the perceived risk to the subjects the IRB may require frequent blood alcohol level (BAL) measurements, based on time intervals or numbers of subjects. The IRB also may approve a limited number of initial human subjects and require submission of BAL measurements for review before approving additional subjects.

The WSU IRB may also request input/review from an outside expert in this area of study.

3.12 Certificate of confidentiality

A certificate of confidentiality helps researchers protect the privacy of human research subjects enrolled in biomedical, behavioral, clinical and other forms of sensitive research. These certificates are issued by the National Institutes of Health (NIH). Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research subject. Any research that collects personally identifiable, sensitive information and that has been approved by an IRB is eligible for a certificate. Federal funding is not a prerequisite for certificate.  More information

3.13 Classroom projects/activities

The IRB does not review classroom projects/activities. Classroom projects/activities are generally considered to be conducted for a class assignment and turned in to the faculty/instructor. If the class assignment involves subjects from vulnerable populations or if the subjects are members of vulnerable populations, the ORA should be contacted for advice and assistance. In certain situations where a class project will be used as part of larger research, IRB review and approval may be required. Contact the IRB coordinator for help and assistance in determining the need for and completing the appropriate application. See additional guidance.

3.14 Graduate student research

IRB policy requires the principal investigator (PI) on an IRB application to be a WSU faculty or staff member. Student initiated research involving human subjects, whether dissertation, thesis, or other research, should include the student as a Co-PI or “other study personnel” when submitted to the IRB for review. Regardless of who fills out the form (e.g. PI, student, research assistant, etc.), the PI is responsible for the content.

IRB review and final approval should take place during the proposal stage of a dissertation or thesis and IRB approval and determination will not be granted retrospectively. Prior to graduation, the Graduate School will require a copy of the graduate student’s IRB approval letter. If it comes to the attention of the IRB that IRB approval has not been obtained for a thesis or dissertation prior to initiation of research involving human subjects, the IRB will refer the student researcher/advisor(s) to the Graduate School.

3.15 Internet- (or online-, computer-) based research

Use of the Internet and other computer-based research methods are evolving rapidly and offering many new methods for researchers to contact research subjects and collect data for research (including opportunities for large numbers of subjects, ease of data collection, possibilities for anonymity, etc.).  All of the same IRB considerations and federal regulations apply; however, use of the Internet also creates challenges for the IRB.

Recruitment

There are many methods of recruitment. Indirect recruitment would include using flyers and announcements that direct individuals to websites to participate in the research. Direct recruitment may include sending e-mails or letters directly to individuals whom the researcher would like to recruit. Researchers should ask themselves the following questions: For direct recruitment, would the subjects reasonably expect the research to contact them regarding the research topic? Authentication can be a major challenge for Internet-based research.  How does the researcher know who they are actually communicating with/recruiting?

Informed consent

Minimal risk research may qualify for a waiver of consent or a waiver of documentation of consent. The IRB would generally require the information normally contained in the consent be provided to subjects so subjects may make an informed decision as to whether to participate. Greater than minimal risk research may require more traditional methods, such as mailing an informed consent document and receiving the subject’s signed copy, although, researchers may present suggestions to the IRB. Again, authentication may be a challenge for Internet based consent.

Anonymity/confidentiality

The Internet and computer-based research can offer a “false sense” of anonymity/confidentiality. The researcher will be required to explain to the IRB how anonymity/confidentiality will be maintained. This will often rely heavily on server administration/security. The use of encryption should be considered and may be encouraged or required by the IRB. Whenever possible, identifiable data should be de-identified. Any code linking data to identities should not be stored on the same server as the data.

Data collection

Depending on the type of data being collected, encryption may be suggested or required.

Data storage/disposal

Whenever possible, personal identifiers should be stored separately from the data and/or the codes linking the data to individuals.  Back-up storage is always a consideration with electronic media. The IRB will be as concerned with security of the back-up material as it is with the original material. Final data destruction of electronic media can be complex. The IRB will want assurance that data deleted is truly not recoverable.

The above discussion is meant as a brief overview. In general, minimal risk research may be well suited for Internet-based activities. Greater than minimal risk research will require careful consideration by the IRB. There may be certain activities that the IRB will not be comfortable approving as Internet-based.

3.16 Recording (photographs, audio, video)

The federal regulations (45 CFR Part 46) require that whenever voice, video, digital, or image recordings are made the application must be reviewed at the expedited review level (provided that the other requirements for expedited review are met) or full-board review.

The type of recording must be disclosed in the informed consent document. When the recording is deemed necessary to the research the informed consent must clearly indicate such. When recording is not absolutely necessary to the researcher a separate signature line for the recording acceptance should be included on the consent form so that a subject could choose to participate in the study but decline the recording of their participation.

The IRB considers recording for purposes of transcription only not to be part of the research that would automatically require expedited review.

3.17 Suicide/depression

Research involving depression indexes and scales can reveal information or disclosures that carry additional responsibilities for the researchers. Studies with suicide or suicidal ideation related questions also require additional safeguards and responsibilities on the part of the researcher. The consent document will also need to contain specific information regarding the risks, resources for counseling, and reportability of certain information.

The IRB will consider to the following:

  • What is the level of risk? A brief depression index or a detailed questionnaire on suicidal ideations?
  • Is the individual obtaining consent or administering the survey/interview qualified to provide counseling? If not, how will counseling be made available?
  • Does the informed consent provide specific phone numbers or locations where counseling services can be accessed by subjects?
  • If a subject expresses the potential to harm themselves or others how will the situation be handled? Who will be contacted? Such situations may require mandatory reporting to law enforcement (this should be disclosed in the informed consent).

3.18 Undergraduate student activities

Undergraduate students may be involved with classroom activities or other research involving human subjects (i.e. surveys, observing behavior, etc.).  In general classroom activities are not included in the IRB’s purview. The IRB coordinator is available to help and assist faculty/instructors. The IRB coordinator is also available to present full or abbreviated human subject education to undergraduate classes.

3.19 Non-regulatory reviews

The trained ORA staff reviews certain activities that involve human subjects but are outside of the federal regulations. Such activities are identified in the IRB decision tree for all projects.  If WSU faculty, staff, or students have questions on the process they should contact the ORA for assistance. Activities that require review in this category will be submitted to the ORA using the non-regulatory application.

4. Applicable regulations and guidelines

21 CFR 812.66

21 CFR 50.24

21 CFR 56.102, 56.104

45 CFR 46.101, 46.103, 46.118, 46.119

5. Forms

None

6. Procedures employed to implement this policy & assignment of responsibility

WhoTask
IRB coordinatorIf necessary, identify and invite appropriate consultant(s) who may assist the IRB in its deliberations
ORA director, IRB coordinator Determine whether the research is exempt from IRB review, eligible for expedited review, or subject to full IRB review.